What’s next for AppliedVR after its FDA De Novo


Late last year, virtual reality therapeutic company AppliedVR scored FDA De Novo clearance for its EaseVRx system for treating chronic lower back pain.  

The eight-week virtual reality program is designed to help people control and modulate their pain, AppliedVR cofounder and CEO Matthew Stoudt told MobiHealthNews. The system uses regulation and mindfulness skills, as well as techniques from cognitive behavioral therapy, to help patients control their physical symptoms alongside other mental and social health problems.

“Chronic pain, like most chronic disease conditions, is what we call a bio-psycho-social condition. And that means that it’s not just simply about the physiology of the pain, but it’s also about the comorbidities of depression, anxiety, catastrophization, sleeplessness,” Stoudt said.

“And then that gets wound into the social side of things, a sense of isolation that patients have. It becomes a vicious cycle.”

Though EaseVRx is currently only approved for chronic lower back pain, the company wants to expand into other clinical areas, including fibromyalgia, osteoarthritis, endometriosis, anxiety and depression.

Like other digital therapeutics, Stoudt said virtual reality companies need to figure out payment and reimbursement for their technologies, but they also need to build out a distribution platform so more users can access their tools.

“As opposed to the traditional class in digital therapeutics where everyone has a cell phone, the infrastructure doesn’t really exist to be able to deliver immersive therapeutics at scale. And so we are in the process of not only building the therapeutic interventions, but also we’ve got to build the infrastructure that’s required to bring this next-generation modality into the marketplace,” he said.

Delivering care at home is an important next step for healthcare, and one that’s been pushed forward by the COVID-19 pandemic, Stoudt said. Other big trends from last year including the focus on telehealth, digital health and mental health – also grew from the lingering impact of the virus on the U.S. healthcare system.

“I think we in the healthcare industry really need to think about rather than forcing the patients to come to the treatments, how do we actually bring healthcare to where the patients are? Meet the patient where he or she is?” he said. “I fundamentally believe that that’s going to be an ongoing trend here.”



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